Clinical Laboratory Improvement Amendments (CLIA)

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

For the following information, refer to the downloads/links listed below:

Information about what is CMS’ authority regarding Laboratory Developed Tests (LDTs) and how does it differ from FDA’s authority is found in the downloads section in the file called "LDT and CLIA FAQs";

CMS Blog - FDA & CMS Form Task Force on LDT Quality Requirements;

Information on research testing and CLIA is found in the file called "Research Testing and CLIA";

Information about direct access testing (DAT) and the CLIA regulations is included in the Direct Access Testing download;

OIG reports relating to CLIA;

Guidance for Coordination of CLIA Activities Among CMS Central Office, CMS Regional Offices, State Agencies (including State with Licensure Requirements), Accreditation Organizations and States with CMS Approved State Laboratory Programs is contained in the Partners in Laboratory Oversight download;

Micro sample pipetting information for laboratories;

Information on alternative (non-traditional) laboratory is contained in the Special Alert download;

FDA Safety Tip for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices; and

Frequently asked questions to S&C-16-18-CLIA, Personnel Policies for Individuals Directing or Performing Non-waived Tests, are in the Downloads section file called "S&C-16-18-CLIA FAQs".

COMPLAINT REPORTING

To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section.

QUESTIONS ABOUT the CLIA PROGRAM

For Questions regarding a CLIA certificate or fees: If you have a question related to CLIA fees or payment, CMS-116 applications, demographic updates, certificate status or upgrades, and/or Laboratory Director changes, please call your local State agency for assistance. Select the State agency based on the physical location of the laboratory. The State agency maintains the certificate information for new and existing laboratory providers within their state. For a list of our State agency CLIA contacts (PDF), please visit our website at /Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf (PDF)